Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Revised Fibromyalgia Impact Questionnaire (FIQR) |
Standard pharmacological treatment usually provided to patients with fibromyalgia. The FIQR comprises three dimensions: physical dysfunction (scores from 0 to 30), overall impact (scores from 0 to 20), and intensity of the symptoms (scores from 0 to 50) is used to measure the impact generated by FM during the last week. It consists of 21 items, which are answered on a numerical rating scale of 11 points (from 0 to 10). Total scores can range from 0 to 100, with higher scores reflecting greater deterioration. |
Change from baseline values at 3 months |
|
Secondary |
Hospital Anxiety and Depression Scale (HADS) |
HADS is used to quantify the severity of anxiety and depression symptoms. It consists of two dimensions (anxiety and depression) of 7 items each responding on a Likert scale of 4 points. Total scores of each scale (HADS-A and HADSD) range from 0 to 21, where higher scores indicate greater severity of symptoms |
Change from baseline values at 3 months |
|
Secondary |
Short Form-36 Health Survey (SF-36) |
Physical Function of the 36-Item Short Form Survey (SF-36) was used to measure physical function. This dimension comprises a total of 10 items, which are answered on a Likert scale of 3 points. Total scores on each scale are then transformed and can range from 0 to 100, with higher scores indicate better physical function. |
Change from baseline values at 3 months |
|
Secondary |
Tampa Scale for kinesiophobia (TSK-11) |
TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and Movement. |
Change from baseline values at 3 months |
|
Secondary |
Multidimensional Fatigue Inventory (MFI) |
Change from baseline values at 6 months] MFI is used to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Its consists in a 20-item scale designed. Participants utilize a 7-point scale to express the extent to which specific statements accurately reflect their fatigue experiences. Several positively phrased items are reverse-scored. Greater overall scores indicate higher levels of fatigue severity. |
Change from baseline values at 3 months |
|
Secondary |
Pain Catastrophising Scale (PCS) |
PCS is used to evaluate catastrophic thoughts associated with pain. It consists of three dimensions (rumination, magnification, and helplessness) of 13 items in total, which are answered on a Likert scale of 5 points. Total scores on each scale range from 0 to 52, with higher scores indicating more catastrophic thoughts |
Change from baseline values at 3 months |
|
Secondary |
Psychological inflexibility in pain scale (PIPS) |
A 12-item scale that assesses psychological inflexibility in pain patients and includes two factors: avoidance and cognitive fusion with pain. Respondents are asked to rate items on a 7-point scale that ranges from 1 (never true) to 7 (always true). Higher scores indicate greater levels of psychological inflexibility. |
Change from baseline values at 3 months |
|
Secondary |
The Patient Global Impression of Change (PGIC) |
Is a measure that has been frequently used as indicators of meaningful overall change [on a 7-point Likert scale, from 1 = "Much better" to 7 = "Much worse"] in treatments for chronic pain. |
Change from baseline values at 3 months |
|
Secondary |
Pain Specific Impression of Change (PSIC) |
The PSIC asks about the impression of change in more specific domains than PGIC: physical and social functioning, work-related activities, mood, and pain [on a 7-point Likert scale, from 1 = "Much better" to 7 = "Much worse"]. |
Change from baseline values at 3 months |
|
Secondary |
Credibility/Expectancy Questionnaire (CEQ) (Adapted version) |
This is a 6-item test used to assess treatment expectations (3 items) as well as credibility (3 items). After the treatment, the test is administered with the questions reformulated in the past tense. |
Change from baseline values at 3 months |
|
Secondary |
Adverse effects of treatments |
Ad hoc measure to check for the presence of negative effects of psychological treatments. |
Change from baseline values at 3 months |
|
Secondary |
Socio-demographic questionnaire |
Gender, date of birth, marital status, living arrangements, educational level and employment status. |
Change from baseline values at 3 months |
|